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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04498364
Other study ID # IRB00256962
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 18, 2020
Est. completion date October 17, 2023

Study information

Verified date October 2023
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aversive sensory phenomena such as premonitory urges play a central role in the behavioral treatment model of tics. Extinction learning and extinction recall are learning processes implicated within this model, but are still understudied for individuals with Tourette syndrome (TS). This study examines extinction learning and extinction recall in adults with TS using an experimental task. This study will also explore the relationship between extinction processes (i.e., extinction learning and extinction recall) and treatment outcomes with behavior therapy. Findings from this investigation will be used to update the behavioral treatment model, which serves as the basis for evidence-based behavioral interventions.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date October 17, 2023
Est. primary completion date September 22, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - At least 18 years old, - Have moderate tic severity or greater as evidenced by a YGTSS Total Tic Score greater than 13 (>9 for youth with motor or vocal tics only) - Have not received more than 4 previous sessions of HRT - Be fluent in English - Medication free or on a stable dose of psychiatric medication for 8 weeks prior to enrollment. Exclusion Criteria: - An inability to complete rating scales - An inability to attend study visits

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Habit Reversal Training
Habit Reversal Training (HRT) is a multi-component evidence-based treatment for tics.

Locations

Country Name City State
United States Johns Hopkins University School of Medicine Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tic severity as assessed by the Hopkins Motor and Vocal Tic Scale (HM/VTS) Patient will nominate up to five motor and five vocal tics they deem bothersome on the HM/VTS. Each bothersome tic is then rated by a clinician on the composite two (vocal and motor) 5-point HM/VTS scale ranging from none (0) to severe (4) for the motor as well as vocal tics. The individual tic scores are summed (minimum of 0 and maximum of 40) and averaged together to create an average tic severity score. Within 1 week after completion of HRT
Secondary Tic severity as assessed by the Yale Global Tic Severity Scale-Revised (YGTSS) The YGTSS is a clinician-rated semi-structured interview that measures tic symptom severity over the previous week. It consists of 10-items that assess different dimensions of tic severity for motor and vocal tics, which are rated on a 0-5 scale. The YGTSS produces a Total Tic Score (range: 0-50), with higher ratings indicating greater tic severity. The YGTSS has demonstrated treatment sensitivity to pharmacotherapy and behavioral interventions. Within 1 week after completion of HRT
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